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Basal Cell CarcinomaPhase 2NCT01367665

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

A Phase 2 study testing vismodegib in people with Basal Cell Carcinoma, run by Hoffmann-La Roche at 181 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
vismodegib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,232 participants
Where
181 sitesin 37 countries
Study dates
1 Jul 2011to 14 Jun 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/=18 years of age
  • Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Who cannot join

  • Concurrent anti-tumor therapy
  • Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
  • Uncontrolled medical illness

Trial locations and contacts

181 sites in 37 countries.

181 sites in 37 countries

Germany31 sites

  • Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle

    Berlin, 10117

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Elbekliniken Buxtehude; Klinik für Dermatologie

    Buxtehude, 21614

  • Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

    Cologne, 50937

  • Klinikum Dortmund gGmbH Klinikzentrum Mitte

    Dortmund, 44137

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf; Hautklinik

    Düsseldorf, 40225

  • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

    Erfurt, 99089

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt, 60590

  • Universitätsklinikum Freiburg Universitäts-Hautklinik

    Freiburg im Breisgau, 79104

  • Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen

    Greifswald, 17489

  • Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Klinikum am Gesundbrunnen; Tumorzentrum

    Heilbronn, 74078

  • Klinikum Kassel; Hautklinik

    Kassel, 34125

  • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

    Kiel, 24105

  • Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)

    Lübeck, 23562

  • Klinikum d.Stadt Ludwigshafen Hautklinik

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

    Magdeburg, 39120

  • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

    Mannheim, 68167

  • Universitätsklinikum Marburg Klinik f. Dermatologie

    Marburg, 35043

  • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

    München, 80337

  • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie

    München, 80802

  • Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie

    Münster, 48149

  • Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

    Nuremberg, 90419

  • Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie

    Quedlinburg, 06484

  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

    Regensburg, 93053

  • Universitaets-Hautklinik Tuebingen

    Tübingen, 72076

  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

    Würzburg, 97080

Other trials in Germany

Spain22 sites

  • Fundacion Hospital de Alcorcon; Servicio de Dermatologia

    Alcorcón, Madrid, 28922

  • Hospital Universitario del Sureste; Servicio de Dermatologia

    Arganda, Madrid, 28500

  • Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

    Barcelona, 08025

  • Hospital Clinic i Provincial; Servicio de dermatología

    Barcelona, 08036

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Hospital Reina Sofia; Servicio de dermatología

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

    Granada, 18014

  • Hospital General Universitario de Guadalajara; Servicio de Dermatologia

    Guadalajara, 19002

  • Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia

    Las Palmas de Gran Canaria, LAS Palmas, 35020

  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia

    León, 24071

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia

    Murcia, 30008

  • Hospital Univ. Central de Asturias; Servicio de Dermatologia

    Oviedo, Principality of Asturias, 33006

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra; Servicio de Dermatologia

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia

    Santa Cruz de Tenerife, Tenerife, 38010

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia

    Toledo, 45004

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 41014

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Universitario Miguel Servet; Servicio Dermatologia

    Zaragoza, 50009

Other trials in Spain

Italy21 sites

  • A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

    Ancona, The Marches, 60121

  • Policlinico Sant'Orsola Malpighi; U.O. Dermatologia

    Bologna, Emilia-Romagna, 40138

  • Università di Brescia; Dipartimento di Dermatologia

    Brescia, Lombardy, 25123

  • Ospedale Antonio Perrino; Oncologia Medica

    Brindisi, Apulia, 72100

  • Ospedale Armando Businco; Dermatologia

    Cagliari, Sardinia, 09121

  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

    Candiolo, Piedmont, 10060

  • Ospedale IOT- Palagi Dermatologia 2

    Florence, Tuscany, 50125

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

    L’Aquila, Abruzzo, 67100

  • I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

    Padova, Veneto, 35128

  • Azienda Ospedaliera Umberto I; Clinica Dermatologica

    Rome, Lazio, 00100

  • Fondazione Ptv Policlinico Tor Vergata; Dermatologia

    Rome, Lazio, 00133

  • Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica

    Rome, Lazio, 00144

  • Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

    Rome, Lazio, 00167

  • IRCCS Istituto Clinico Humanitas; Farmacia

    Rozzano, Lombardy, 20089

  • A.O.U. Senese Policlinico Santa Maria Alle Scotte

    Siena, Tuscany, 53100

Other trials in Italy

France11 sites

  • Hopital Saint Andre CHU De Bordeaux; Dermatologie

    Bordeaux, 33075

  • Hopital Ambroise Pare; Sce Dermatologie

    Boulogne-Billancourt, 92100

  • Chu Site Du Bocage;Dermatologie

    Dijon, 21079

  • Hopital Claude Huriez; Sce Dermatologie

    Lille, 59037

  • Hopital Timone Adultes; Dermatologie

    Marseille, 13385

  • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

    Montpellier, 34295

  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique

    Nantes, 44093

  • Hopital Saint Louis; Dermatologie 1

    Paris, 75475

  • Centre Hospitalier Lyon Sud; Dermatologie

    Pierre-Bénite, 69495

  • Hôpital Larrey Université Paul Sabatier; Service Dermatologie

    Toulouse, 31000

  • Institut Gustave Roussy; Comite 5

    Villejuif, 94805

Other trials in France

Czechia7 sites

  • Nemocnice Ceske Budejovice

    České Budějovice, 370 87

  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

    Hradec Králové, 500 05

  • Fakultní nemocnice Ostrava; Kožní oddělení

    Ostrava, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

    Prague, 140 59

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

United Kingdom7 sites

  • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

    Cambridge, CB2 0QQ

  • Western Infirmary; Division of Cardiovascular and Medical Sciences

    Glasgow, G11 6NT

  • St Thomas Hospital

    London, SE1 7EH

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Freeman Hospital; Northern Centre For Cancer Care

    New Castle Upon Tyne, NE7 7DN

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada6 sites

  • Western Canada Dermatology Institute

    Edmonton, Alberta, T5J 3S9

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Victoria Park MediSpa

    Montreal, Quebec, H3Z 1C3

  • Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

    Québec, G1V 4X7

  • Dr. Nowell Solish Cosmetic Dermatology

    Toronto, Ontario, M5R 3N8

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Colombia5 sites

  • Inst. Nacional de Cancerologia; Clinica de Seno

    Bogotá

  • Riesgo De Fractura; Rheumatology

    Bogotá

  • Hemato Oncologos S.A.

    Cali

  • Reumalab Sas; Rheumatology

    Medellín

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

Other trials in Colombia

Greece5 sites

  • Laiko General Hospital; 1St Pathological Clinic

    Athens, 115 27

  • Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department

    Athens, 16121

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University General Hospital of loannina; Dermatology and Venereal Diseases Clinic

    Ioannina, 455 00

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546 45

Other trials in Greece

Hungary5 sites

  • Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

    Budapest, 1085

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

    Debrecen, 4012

  • Kaposi Mor Teaching Hospital

    Kaposvár, 7400

  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

    Szeged, 6720

Other trials in Hungary

Romania5 sites

  • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

    Bucharest, 022328

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Spital Clinic Judetean Mures; Oncologie

    Târgu Mureş, 540142

  • S.C. Life Search S.R.L; Medical Oncology Clinic

    Timișoara, 300167

Other trials in Romania

Turkey (Türkiye)5 sites

  • Ankara Numune Training and Research Hospital; Dermatology

    Ankara, 06100

  • Gazi Universitesi Tip Facultesi; Dept. of Dermatology

    Ankara, 06500

  • Istanbul Uni of Medicine Faculty; Oncology Dept

    Istanbul, 34390

  • Dokuz Eylul University Medicine Faculty; Dermatology

    Izmir, 35340

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Australia4 sites

  • CMAX A division of IDT Australia Limited

    Adelaide, South Australia, 5000

  • Skin & Cancer Foundation

    Carlton, Victoria, 3053

  • Premier Specialists

    Kogarah, New South Wales, 2217

  • Skin and Cancer Foundation Australia

    Westmead, New South Wales, 2145

Other trials in Australia

Austria4 sites

  • LKH Graz; Abteilung für allgemeine Dermatologie

    Graz, 8036

  • LKH Salzburg; Universitätsklinik für Dermatologie

    Salzburg, 5020

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien; Univ.Klinik für Dermatologie

    Vienna, 1090

Other trials in Austria

Israel4 sites

  • Rambam Medical Center

    Halfa, 31096

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Sheba Medical Center; Tel Hashomer

    Ramat Gan, 5262100

Other trials in Israel

Netherlands4 sites

  • Academ Ziekenhuis Groningen; Medical Oncology

    Groningen, 9713 GZ

  • LUMC; Dermatologie

    Leiden, 2333 ZA

  • Maastricht University Medical Centre; Dermatologie

    Maastricht, 6229 HX

  • Erasmus MC; Dermatology

    Rotterdam, 3015 GD

Other trials in Netherlands

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • DERMED Centrum Medyczne; Sp zoo

    Lodz, 90-265

  • Centrum Diagnostyki Znamion

    Poznan, 61-821

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

    Warsaw, 00-973

Other trials in Poland

Russia4 sites

  • FSBI "National Medical Research Center of Oncology N.N. Blokhin"

    Moscow, 115478

  • Moscow city oncology hospital #62 of Moscow Healthcare Department

    Moscow, 143423

  • FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

    Saint Petersburg, Sankt-Peterburg, 197758

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 197022

Other trials in Russia

Brazil3 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Bosnia and Herzegovina2 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100

Other trials in Bosnia and Herzegovina

Bulgaria2 sites

  • District Oncology Dispensary; Department for Oncology and Dermatology

    Plovdiv, 4000

  • National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

    Sofia, 1756

Other trials in Bulgaria

Finland2 sites

  • Helsinki University Central Hospital; Skin & Allergy Hospital

    Helsinki, 00029

  • Kuopion yliopistollinen sairaala

    Kuopio, 70211

Other trials in Finland

Ireland2 sites

  • Cork University Hospital; Dermatology Dept

    Cork

  • St Vincent'S Uni Hospital; Medical Oncology

    Dublin, 4

Other trials in Ireland

Serbia2 sites

  • Institute for Oncology and Radiology of Serbia; Medical Oncology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

Other trials in Serbia

Sweden2 sites

  • Skånes Onkologiska Klinik, Universitetssjukhuset

    Lund, 22185

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 113 41

Other trials in Sweden

Argentina1 site

  • Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia

    Buenos Aires, 1417

Other trials in Argentina

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Croatia1 site

  • Clinical Hospital Sisters of Mercy

    Zagreb, 10000

Other trials in Croatia

Denmark1 site

  • Herlev Hospital; Onkologisk afdeling

    Herlev, 2730

Other trials in Denmark

Lithuania1 site

  • National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

Mexico1 site

  • Hospital General de México

    Mexico City, Mexico CITY (federal District), 06726

Other trials in Mexico

New Zealand1 site

  • Waitemata District Health; General Surgery

    Takapuna, 0620

Other trials in New Zealand

Norway1 site

  • Oslo Universitetssykehus HF; Radiumhospitalet

    Oslo, 0310

Other trials in Norway

Portugal1 site

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Slovakia1 site

  • Fakultna Nemocnica Roosevelta

    Banská Bystrica, 975 17

Other trials in Slovakia

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

Switzerland1 site

  • Universitätsspital Zürich; Dermatologische Klinik

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

Being tested
vismodegib
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vismodegibDrug

    150 mg once daily until disease progression or unacceptable toxicity

Study groups in NCT01367665
Study groupRoleWhat they receive
Vismodegib - Locally AdvancedExperimentalParticipants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
Receives: Drug: vismodegib
Vismodegib - MetastaticExperimentalParticipants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
Receives: Drug: vismodegib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)

    Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  2. Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons

    Reasons for "other" included "unknown," "natural causes," "cardiac decompensation," "general state alteration," "deterioration of general state," "clinical deterioration taking into consideration patient's age," "old age," and "disease progression of mediastinal squamous cell carcinoma (SCC)."

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  3. Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  4. Exposure to Study Treatment: Duration on Treatment

    Duration on treatment was the number of days between first and last dose of study treatment.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  5. Exposure to Study Treatment - Dose Intensity

    Dose intensity was defined as the percentage of actual number of doses received versus planned.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Secondary outcomes (8)

  1. Best Overall Response Rate (BORR)

    BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  2. Duration of Response

    Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  3. Time to Response

    Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first).

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  4. Progression-Free Survival (PFS)

    PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  5. Overall Survival (OS)

    OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.

    Measured: Baseline to the data cut-off of 14 June 2017 (up to 6 years)

  6. Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom

    The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst).

    Measured: Baseline to the data cut-off date of 14 June 2017 (up to 6 years).

  7. Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale

    M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.

    Measured: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

  8. Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale

    M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.

    Measured: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2011 (estimated)
  2. Study start1 Jul 2011
  3. Primary completion14 Jun 2017
  4. Study completion14 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01367665
Sponsor's protocol ID
MO25616
Other IDs
2011-000195-34
Status last verified
Mar 2019
First submitted
30 May 2011
Last updated
6 Jun 2019

Publications

  • Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.

    PubMed 32374193

  • Basset-Seguin N, Hauschild A, Kunstfeld R, Grob J, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Meyer N, Guillot B, Dummer R, Arenberger P, Fife K, Raimundo A, Dika E, Dimier N, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334-348. doi: 10.1016/j.ejca.2017.08.022. Epub 2017 Nov 5.

    PubMed 29073584

  • Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Jouary T, Meyer N, Guillot B, Dummer R, Fife K, Ernst DS, Williams S, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. doi: 10.1016/S1470-2045(15)70198-1. Epub 2015 May 13.

    PubMed 25981813

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vismodegib in people with Basal Cell Carcinoma, run by Hoffmann-La Roche at 181 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in Germany, Spain, Italy, France, Czechia and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs) (time frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01367665, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.

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